Kornimate/medical-research-clean huggingface dataset:
consumer perception of an experimental mouthwash after a single use in dry mouth subjects

Conditions: Xerostomia

Summary: the purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth


Eligibility criteria:
inclusion criteria: * demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form * aged 18 - 84 years inclusive * good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination * participant reports having a feeling of a dry mouth according to the dry mouth screening questionnaire (dmsq) (subject must answer at least 2 out of the 4 questions with 'agree a little', 'agree' or 'strongly agree' at the screening visit (visit 1). participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min at the screening visit (visit 1). * participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min ath the screening visit (visit 1). * understands and is willing, able and likely to comply with all study procedures and restrictions exclusion criteria: * women who are known to be pregnant or who are intending to become pregnant over the duration of the study or have a positive urine pregnancy test at the screening visit * women who are breast-feeding * participant is currently undergoing radiotherapy and/or chemotherapy treatment * any condition the investigator identifies that can confound the participant's ability to properly participate in the study e.g. alzheimer's disease * participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration) * evidence of gross intra-oral neglect or need for extensive dental therapy * denture wearer (complete dentures) * participant not on stable doses of prescription systemic parasympathetic medications (e.g. pilocarpine), for the treatment of the feeling of dry mouth * known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients * participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 14 days of the screening visit * previous participation in this study * recent history (within the last 1 year) of alcohol or other substance abuse * an employee of the sponsor or the clinical study team or members of their immediate family. students and employees of the tufts university school of dental medicine not associated with the clinical trials team are eligible to participate. students and employees will not be specifically targeted for enrollment * non-english speaking participants will not be enrolled in the study. participants must be able to read and write in english
study to compare the safety and efficacy of solifenacin with oxybutynin for the treatment of overactive bladder (vector)

Conditions: Overactive Bladder

Summary: the purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (ir) for the treatment of overactive bladder (oab).

this study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 active, active control) comparative parallel group study to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (ir) for the treatment of overactive bladder (oab).

Eligibility criteria:
inclusion criteria: * adults 18 years and older. * overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: \> 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average) exclusion criteria: * urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones * clinically significant outflow obstruction * uncontrolled narrow angle glaucoma, urinary, or gastric retention * severe renal or hepatic impairment * chronic severe constipation or history of diagnosed gi obstructive disease * significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor * diagnosis or history of neurogenic bladder * history of bladder or pelvic cancer

Keywords: solifenacin succinate oxybutynin immediate release xerostomia overactive bladder
strategy for daily activity improvement in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: the symptoms and signs of patients with parkinson's disease (pd) include bradykinesia, rigidity, tremor and poor sensory integration, which result in mobility disability. present integrated research project tries to investigate the effects of different physical therapy interventions on daily activities in patients with pd. this integrated research project includes 3 subprojects as follows. the title of subproject 1 is "three dimensional motion analysis of daily activities with functional insole in parkinsonian patients". the title of subproject 2 is "immediate and long-term effects of novel plantar mechanical device on postural control in standing and gait performance in people with parkinson's disease". the title of subproject 3 is "upper extremity hand function and coordination during functional movement in patients with parkinson's disease". this multidisciplinary research project collaborates with department of physical therapy, and department of medicine in tzu chi university. furthermore, this integrated study also works with department of neurology, department of neurosurgery, as well as department of rehabilitation in tzu chi hospital to improve the mobility in patients with pd. this is a three-year integrated project, and the common purposes of this project in each are as follows. in the first year, it is to compare the daily functional difference between the healthy and the parkinsonian patients. in the second year, it is to examine the immediate and short-term effects of different interventions on daily activities in parkinsonian patients.the third year is for upper extremity functional assessment.

in the first year, it is to compare the functional difference of biomechanics and motor control between the healthy and the parkinsonian patients. in the second year, it is to examine the immediate and short-term effects of functional foot insole and the kinetic training on daily activities in parkinsonian patients. in the third year, it is to examine the hand tremor during drawing, and the coordination during reaching in parkinsonian patients.

Eligibility criteria:
inclusion criteria: * stage ii\~iv of hoehn and yahr staging of parkinson's disease and normal subjects, whose age between 40\~75. exclusion criteria: * brain injury or hemorrhage, including stroke, etc.

Keywords: parkinson disease quality of life physical therapy tremor coordination gait analysis
surgical outcomes, quality of life and patient's satisfactions with phalloplasty

Conditions: Phalloplasty; Surgery

Summary: the phalloplasty is a reconstruction technique, consisting of the neophallus creation. it is performed in transgender patients in sex reassignment surgery, or in cismale patients to correct a congenital or acquired lack of penis. there are many surgical techniques, but none is optimal. surgical and functional outcomes, quality of life and patient's satisfactions with phalloplasty are missing in the international literature. urological center of lyon is a reference center of this kind of surgery and has the possibility to evaluate that. in this study, 124 transgender and 19 cismale patients with phalloplasty are eligible. this study will allow us to adapt our practice to the patient's return and improve the information given to patients before their surgery. it will also improve our surgical techniques, depending on the results achieved.


Eligibility criteria:
inclusion criteria: * major patients * patients who have undergone a phalloplasty surgery in the university lyon sud hospital or croix rousse hospital, between 1 january 2007 and 31 october 2018 * patients with at least one year of back on their surgery procedures * transgender patients whose reassignment surgery was validated by a minimum of three members of grettis (groupe de recherche, d'etude et de traitement des troubles de l'identité sexuelle), including a psychiatrist or patients cis males with congenital malformations, or having suffered a total or partial amputation of verge * patients who do not oppose orally to participate in the study, after information * patients who have given their consent for the audio recording for patients taking part in semi - directive interviews exclusion criteria: * minor patients or patients under legal protection * refusal to participate in the study * no understanding of the french language

Keywords: phalloplasty surgery
the effect of time to start breast milk fortifiers on neonatal outcomes in very low birth weight premature infants.

Conditions: Breast Milk Fortifier Supplements; Premature

Summary: in the study, very low birth weight babies born in our hospital will be randomized in the closed envelope method, and breast milk fortifier will be started when 50 ml/kg/day breastfeeding volume is reached in one group, and breast milk enrichment will be started when 100 ml/kg/day enteral feeding is reached in the other group. in the study, the babies in these two groups will be compared by making early (nutrition characteristics and premature morbidity) and long-term follow-ups. in this study, a 30% reduction in the transition time to full enteral nutrition between the groups corresponds to a difference of approximately 5 days. in our study, the sample size was determined as at least 78 patients in each group, with a margin of error of 0.05 and a power of 80% to show the 5-day difference between the groups.


Eligibility criteria:
inclusion criteria: * preterm babies born weighing less than 1500 grams exclusion criteria: * babies with congenital anomalies * infants who develop necrotizing enterocolitis or spontaneous intestinal perforation before starting a breast milk fortifier * babies lost before reaching 50 cc/kg enteral nutrition * babies who are not breastfed

Keywords: breast milk fortifier nutrition
a study to assess the effects of a single dose of gsk598809 in modulating nicotine reward

Conditions: Substance Dependence

Summary: gsk598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. this study will asses the effects of a single dose of gsk598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke. each cohort of subjects will receive a single dose of placebo or gsk598809 in two dosing sessions binded crossover fashine. there will be a washout period of at least seven days between each session.


Eligibility criteria:
inclusion criteria: * healthy male smokers aged 18-65 with a desire to quit smoking. * body weight greater than 50kg and bmi within range 19 - 29.9 kg/m2 * healthy with no significant medical, psychiatric or laboratory evaluation abnormality. exclusion criteria: * positive pre-study urine drug/breath alcohol screen: positive hiv 1/2, hepatitis b or hepatitis c test at screening. * history of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study. * history of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation. * history of cardiac or pulmonary disease/abnormalities.

Keywords: pharmacodynamics, pharmacokinetics, tolerability, safety, single dose, placebo, nicotine reward gsk598809
the clinical evaluation of efficacy of lipid-lowing tea on hyperlipidemia patients' lipid profiles

Conditions: Hyperlipidemia

Summary: the purpose of this study is to determine whether the lipid-lowing tea is effective and safe in the treatment of hyperlipidemia patients


Eligibility criteria:
inclusion criteria: * patient aged 20-65 years;either sex * patient diagnosed with hyperlipidemia(fasting levels of tc\>=200mg/dl),or tg\>=200mg/dl but \ =130mg/dl) * patient who has signed the informed consent form exclusion criteria: * patient with pregnancy (or child bearing potential),or in lactation * patient with any lipid regulating agents within 4 weeks prior to study period * patient currently taking concomitant medications, such as oral contraceptives, or any medical treatment capable of interfering with lipid metabolism(eg thiazides, β-blockers, cyclosporins, itraconazole erythromycin,and danazol) * patient with medical history of hypothyroidism, pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, primary biliary cirrhosis. * patient with liver dysfunction (sgot or sgpt\>2x uln) * patient with renal insufficiency (serum creatinine\>1.3mg/dl) * patient with myocardial infarction,cerebrovascular disease,or major operations within 6 months prior to the study period.
study of qlc7401 in the treatment of primary hypercholesterolemia or mixed hyperlipidemia with elevated ldl cholesterol

Conditions: Primary Hypercholesterolemia or Mixed Hyperlipidemia

Summary: to evaluate the efficacy, safety, pharmacodynamics and immunogenicity of qlc7401 subcutaneous administration in patients with primary hypercholesterolemia or mixed hyperlipidemia with poorly controlled ldl-c elevated on optimized lipid-lowering therapy.


Eligibility criteria:
inclusion criteria: * male or female participants aged ≥18 years of age. * serum ldl-c ≥1.8mmol/l for ascvd participants or ≥2.6mmol/l for other participants at screening. * fasting tg \<400mg/dl (\<4.5mmol/l) at screening. * stable lipid-lowering therapy for ≥4 weeks at randomization. * understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent. exclusion criteria: * having the following diseases or treatment history: (1) cardiac function as defined by the new york heart association (nyha) grade ii-iv at screening or randomization or latest detected lvef\<30%; (2) cvd events within 3 months; (3) uncontrolled severe hypertension; (4) previous diagnosis of familial hypercholesterolemia; (5) have known allergic reaction to experimental drug, or have severe allergic reaction to other drugs; (6) inadequate organ functions or malignancy history; (7) prior exposure to other rna inhibitors within 2 years. * any of the laboratory indicators met the following criteria at screening or at randomization: (1) alt or ast exceeding 2 times the upper limit of normal (uln), or total bilirubin exceeding 1.5 times uln; (2) creatine kinase (ck) exceeding 3 times uln; (3) tsh is less than the lower limit or normal (lln) or exceeds 1.5 times uln. * general conditions: (1) male or female participants who do not agree to use high-efficiency contraceptives during the trial and for 6 months after the last dosing; (2) women who are pregnant or lactating. * the investigator determines that the participants have poor compliance or have any factors that may prevent them from participating in the study.
seeme: an automated tool to detect early recovery after brain injury

Conditions: Disorder of Consciousness; Consciousness, Loss of; Trauma, Brain; Traumatic Brain Injury; Acute Brain Injury

Summary: early prediction of outcomes after acute brain injury (abi) remains a major unsolved problem. presently, physicians make predictions using clinical examination, traditional scoring systems, and statistical models. in this study, we will use a novel technique, "seeme," to objectively assess the level of consciousness in patients suffering from comas following abi. seeme is a program that quantifies total facial motion over time and compares the response after a spoken command (i.e. "open your eyes") to a pre-stimulus baseline.

acute brain injury (abi) recovers at a variable rate. while some progress has been made in predicting long-term outcomes in traumatic brain injury (tbi) and intracranial hemorrhage, there is a critical need for short-term prediction of outcomes, in the first days and weeks after injury. with advances in machine learning and artificial intelligence, there is a growing interest in facial analysis and its application in neurological and psychiatric disorders. here we describe "seeme," a novel automated objective measure of consciousness based on microexpression analyses in response to auditory commands. in measuring the smallest muscular movements undetectable by clinical observation, this technique has the high spatial resolution needed to detect hidden signs of recovery and the high temporal resolution needed to study neural circuits.

Eligibility criteria:
inclusion criteria: * 18 years old or older * healthy volunteers * comatose patients (patients with a gcs \< 9) due to an acute brain injury (traumatic brain injury, spontaneous subarachnoid hemorrhage, severe meningoencephalitis, etc.) exclusion criteria: * a history of a neurologically debilitating disease (i.e., dementia, glioblastoma, alzheimer's, multiple sclerosis, major vessel stroke, previous severe tbi, etc.) * any other medical condition that, in the judgment of the investigator, makes participation in the study unsafe. * pregnant subjects * comatose patients without a legal authorized representative (lar) * prisoners or wards of the state * persons who have not attained the legal age for consent to treatments or procedures

Keywords: consciousness acute brain injury consciousness recovery consciousness measurement facial motion analysis microscopic movements traumatic brain injury
new relapse model in psychiatry

Conditions: Alcohol Use Disorder

Summary: the goal of this clinical trial is to learn about risk factors of relapse in patients with alcohol use disorder. the main questions it aims to answer are : * among patients with alcohol use disorder, are there clusters of patients with the same characteristics and the same outcome ? * which are the risk factors of relapse that are the most predictive ? do they vary according to cluster? * can a feedback-measurment-system (eg : a feedback of the tests' results) be usefull in a detoxification unit ? participants will : * complete auto-questionnaires * pass hetero-evaluations * undergo an electrophysiological battery


Eligibility criteria:
inclusion criteria: * to suffer from aud * to be hospitalized * to speak french fluently * to be able to give their consent (medically and legally). exclusion criteria: * to suffer from severe perceptive disabilities (auditory, visual) * to suffer from severe cognitive impairment

Keywords: clustering relapse feedback-measurment-system
influence of intrapulmonary percussive ventilation (ipv) on gastro-oesophageal reflux (gor).

Conditions: Gastro-oesophageal Reflux

Summary: the study evaluates the effect on gastro-oesophageal reflux (gor) of infants sitting in a stable upright position during 20 min. this is an addendum to the previous study with record number clinical trials.gov nct02124863


Eligibility criteria:
inclusion criteria: * each child under the age of one year that was referred for 24h ph-mii monitoring to exclude pathological gastro-oesophageal reflux (gor) exclusion criteria: * : prematurity (gestational age less than 37 weeks), the use of anti-reflux medication and reflux surgery (nissen fundoplication)

Keywords: gastro-oesophageal reflux intrapulmonary percussive ventilation positioning
diabetes prevention program for obese latino youth

Conditions: Obesity; Insulin Resistance; Diabetes

Summary: the purpose of this study is to examine the effects of 12 week lifestyle intervention on diabetes risk in obese latino adolescents.

obesity in the united states has reached epidemic proportions and latinos youth are disproportionally impacted. pediatric obesity is associated with several chronic health conditions including insulin resistance and type 2 diabetes. however, very few interventions specifically targeting diabetes prevention for obese latino adolescents have been developed. therefore, the purpose of this study is to examine the effects a culturally-grounded, community-based lifestyle intervention on psychosocial and health outcomes among obese latino adolescents. eligible participants of this study will be randomly selected to the intervention group or the delayed-intervention group (control group) after an initial health screening for eligibility. participants selected to the intervention group will attend weekly healthy lifestyle education sessions with their parent(s)/guardian(s) and three physical activity sessions / week with other youth. after which, participants will attend monthly booster group meetings for three months. all participants will be assessed at baseline, 3 months, 6 months, and 12 months for insulin sensitivity, glucose tolerance, quality of life, fitness, and nutrition and physical activity behaviors.

Eligibility criteria:
inclusion criteria: * latino: self-report by parents * age: 14-16 * obese: bmi percentile \>= 95th percentile for age and gender or bmi \>= 30 kg/m\^2 exclusion criteria: * taking medication(s) or diagnosed with a condition that could influence carbohydrate metabolism, physical activity, and/or cognition * type 2 diabetes: fasting plasma glucose \>= 126 mg/dl or 2-hour plasma glucose \>= 200 mg/dl (youth found to be diabetic through study's procedures will be referred for follow up care and excluded) * recent hospitalizations (previous 2 months) * currently enrolled in (or with in previous 6 months) a formal weight loss program * diagnosed depression or other condition that may impact qol

Keywords: diabetes prevention program community based interventions childhood obesity insulin resistance glucose tolerance quality of life latino youth physical activity nutrition
clinical study evaluating safety of a new catheter for urinary intermittent catheter in healthy volunteers

Conditions: Spinal Cord Injury

Summary: to evaluate discomfort of a new coating and catheter material compared to speedicath (sc)

intermittent catheterization is the preferred method for emptying the bladder in patients with spinal cord injury and neurogenic bladder dysfunction. coloplast have developed a new intermittent catheters. in this investigation this new test catheter will be compared with speedicat by assessing discomfort and pain associated with catheterization of healthy men. the reason for choosing healthy men is that many catheter users do not have full feeling in their urethra and therefore can not assess the discomfort. 55 healthy men who are ≥ 18 years and have no signs of urinary tract infection and do not have abnormalities, disease or have had operational interventions in the urinary tract will be included. they are recruited through advertisements on the website www.forsoegsperson.dk.

Eligibility criteria:
inclusion criteria: * • ≥18 years * male * signed informed consent * negative urine stix (erythrocytes, leucocytes and nitrite) exclusion criteria: * • abnormalities, diseases or surgical procedures performed in the lower urinary tract